Montelukast for the high impact of asthma exacerbations in Venezuela: a practical and valid approach for Latin America?

BACKGROUND: Asthma affects mainly Venezuela's urban and poor majority. Exacerbations bring about a high demand in health services, thus becoming a significant public health problem. In general, asthma control programs (GINA) with use of inhaled steroid medications have proven effective, although their implementation in real life remains cumbersome. Montelukast could be a useful and practical tool for these deprived socioeconomic sectors. METHODS: This real-life pilot study was conducted in a prospective, double blinded, placebo-controlled manner with randomized and parallel groups. Asthmatics that had never used leukotriene modifiers were recruited and followed-up every three months. The main outcome was the number of exacerbations meriting use of nebulized bronchodilators administered by the health care system. RESULTS: Eighty-eight asthmatic patients were enrolled, between children and adults. Groups were comparable in: demographic data, previous use of other medications, ACT scores, pulmonary functions (Wright Peak Flow meter), allergy status (Skin Prick Test) as well as adherence to the prescribed Montelukast treatment. By an intention to treat (ITT), a total of 64 patients were included for analysis. For the three and six months time points the difference between placebo and Montelukast was found to be significant (p < 0.03 and p < 0.04, respectively). Such trends continued for the rest of the year, but without statistical significance, due to patient attrition. CONCLUSIONS: This real-life pilot study shows that a simplified strategy with oral Montelukast was practical and effective in controlling exacerbations in an asthmatic population of a vulnerable community from Caracas. Such an approach reinforces the role of primary care in asthma treatment.

Home/social environment and asthma profiles in a vulnerable community from Caracas: lessons for urban Venezuela?

BACKGROUND: Asthma is a significant public health problem in Venezuela affecting the predominantly urban and poor majority of the population. Information regarding home and the social environment, key elements in asthma, is found to be deficient in these deprived socioeconomic sectors. This study was carried out to depict a life with asthma in this context which has been served over the years by a National Asthma Control Program. METHODS: A survey of families residing in a socioeconomically deprived community of Caracas was carried out with the assumption that this community reflects the image of a life with asthma emanating from our deprived urban areas. Home physical settings were inspected for the following items: moldy walls, floors, ceilings, windows, sewage, garbage disposal, running water, plumbing, electricity, telephone, construction debris, furniture, bathrooms, food storage, and home appliances. In addition, we also gathered information regarding smoking habits, fumes exposure, pets and/or animals, and sighting of roaches and/or rodents. The presence of people with asthma was observed and their status of control was assessed through the asthma control test (ACT). Comparisons were made between families with asthmatics and those without asthmatics. RESULTS: Randomly, 242 of 750 families (32.26%) were surveyed, with "head of family" providing information (75.6%) on most occasions. No significant association was found with respect to the previously explored items in those families with or without the presence of asthmatics. Medically diagnosed asthma was found in 14.91%, with ACT scores of <19 points in two-thirds of these adults and asthmatic children. Asthmatics reported symptoms occurring mostly during the night and an almost exclusive use of rescue medications. Families provided most treatments and children preferred to use the oral route for control medications. Significant work and school absenteeism were detected in more than 50% of these asthmatics. CONCLUSIONS: No physical home environmental/risk factors turned out to be significantly associated with families reporting the presence of asthmatics. The high impact of asthma found in this Caracas slum underscores the realities of Venezuela's impoverished urban majority. To properly address this important challenge, our National Asthma Control Program needs to be reassessed.

Efficacy and tolerability of conventional nimesulide versus Beta-cyclodextrin nimesulide in patients with pain after surgical dental extraction: a multicenter, prospective, randomized, double-blind, double-dummy study.

BACKGROUND: Pain following extraction of an impacted third molar is widely used to assess analgesic efficacy, especially that of a single dose of a drug. The analgesic activity of conventional nimesulide (CN) has been documented in a variety of types of acute and chronic pain. Beta-cyclodextrin nimesulide (BN) is a new formulation in which nimesulide is included in a cyclodextrin molecule, which increases its solubility in water and its dilution rate, allowing extended, rapid absorption of the drug. OBJECTIVE: The aim of this study was to assess the efficacy and tolerability of a single dose of BN compared with CN in patients with pain following extraction of an impacted third molar. METHODS: This was a prospective, randomized, double-blind, double-dummy study conducted at 3 dentistry centers in Venezuela. The patients were randomized to 1 of 2 groups. One group received a single dose of BN (400-mg tablet, equivalent to 100 mg of nimesulide); the other group received a single dose of CN (100-mg tablet). Both groups also received a placebo. The efficacy variables were (1) pain intensity (PI), assessed on a visual analog scale (VAS) at the following times: 0, 5, 10, 15, 30, and 45 minutes and 1, 2, 4, 6, 8, 10, and 12 hours after drug administration; (2) time to first measurable difference in PI from baseline (PID) (PID ≥1 cm on the VAS; ie, the beginning of analgesic action); (3) maximum PID (max PID); (4) sum of PIDs in the 12-hour observation period; (5) pain relief (PR), as rated on a 5-point scale; (6) maximum PR; and (7) sum of the PR scores in the 12-hour observation period (ie, total PR). For the tolerability analysis, all adverse events (AEs) were to be recorded, and the investigators were to assess whether each AE was drug related. RESULTS: Seventy-two patients were enrolled in the study. Of these, 62 patients (40 women, 22 men; mean [SD] age, 20.1 [5.9] years) were assessed; 35 were treated with BN and 27 with CN. PI reduction was more rapid and greater in the BN group. The first measurable change in PI (PID ≥1 on the VAS) was reached within 5 minutes by 39% and 15% of the patients in the BN and CN groups, respectively, and within 10 minutes by 52% and 30% of the patients in the BN and CN groups, respectively. The max PID was reached <1 hour in 32% and 15% of patients in the BN and CN groups, respectively. No AEs were reported. CONCLUSIONS: In this study population, both BN and CN were similarly effective in relieving pain after extraction of an impacted third molar, and both drugs were well tolerated. PI changes were statistically significantly more rapid and greater with BN than CN.